Last reviewed 2026-04-20 · How we verify

Gadavist (GADOBUTROL)

Gadavist works by binding to gadolinium ions, which then accumulate in body tissues and enhance MRI signal.

Gadavist (Gadobutrol) is a gadolinium-based contrast agent developed by Bayer Healthcare, used for magnetic resonance imaging (MRI). It is a small molecule modality that was FDA approved in 2011 for various MRI indications. Gadavist is off-patent and has generic manufacturers. Key safety considerations include the potential for nephrogenic systemic fibrosis in patients with severe kidney impairment. As a gadolinium-based contrast agent, Gadavist works by enhancing the visibility of internal body structures during MRI.

At a glance

Mechanism of action

In MRI, visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with:oDifferences in proton densityoDifferences of the spin-lattice or longitudinal relaxation times (T1)oDifferences in the spin-spin or transverse relaxation time (T2)When placed in magnetic field, Gadavist shortens the T1 and T2 relaxation times. The extent of decrease of T1 and T2 relaxation times, and therefore the amount of signal enhancement obtained from Gadavist, is based upon several factors including the concentration of Gadavist in the tissue, the field strength of the MRI system, and the relative ratio of the longitudinal and transverse relaxation times. At the recommended dose, the T1 shortening effect is observed with greatest sensitivity in T1-weighted magnetic resonance sequences. In T2-weighted sequences the induction of local magnetic field inhomogeneities by the large magnetic moment of gadolinium and at h

Approved indications

• Magnetic resonance imaging

Boxed warnings

• WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadobutrol injection is not approved for intrathecal use [see Warnings and Precautions ( 5.1 )] . Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of drugs. Avoid use of gadobutrol injection in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. • The risk for NSF appears highest among patients with: o Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or o Acute kidney injury. • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. • For patients at highest risk for NSF, do not exceed the recommended gadobutrol injection dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions ( 5.2 )] . WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning • Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadobutrol injection is not approved for intrathecal use ( 5.1 ) • GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of drugs. Avoid use of gadobutrol injection in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. • The risk for NSF appears highest among patients with: o Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or o Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. ( 5.2 ).

Common side effects

• Headache
• Nausea
• Dizziness
• Dysgeusia
• Feeling Hot
• Injection site reactions
• Vomiting
• Rash
• Erythema
• Paresthesia
• Pruritus
• Dyspnea

Key clinical trials

• The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study (NA)
• Dotarem vs Gadobutrol Contrast for Breast MRI (PHASE4)
• A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients (PHASE2,PHASE3)
• Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
• Novel Imaging Technique to Assess Gynecologic Cancer (PHASE1)
• Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease (NA)
• A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Central Nervous System (CNS) Lesions (PHASE3)
• Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years (PHASE4)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Gadavist CI brief — competitive landscape report
• Gadavist updates RSS · CI watch RSS
• Bayer portfolio CI